Berlin-headquartered Atai Life Sciences (Nasdaq:ATAI) is sharing positive initial results from a Phase 1 clinical study of KUR-101, an oral formulation of deuterated mitragynine, in patients with opioid use disorder.
Mitragynine is a primary active alkaloid of the kratom plant (Mitragyna speciosa).
Atai’s KUR-101 is an oral formulation of deuterated mitragynine. Atai subsidiary Kures is leading the development of the drug. Kures is a spin-out from Columbia University.
In its recent placebo-controlled Phase 1 study, the drug appeared to be safe and well-tolerated in most patients. In addition, the study found that KUR-101 led to minimal changes in respiratory rate.
Kratom is a controversial botanical. Native to Southeast Asia, kratom has been banned in various countries owing to its opioid-like effects. In 2016, the Drug Enforcement Agency in the U.S. announced its intent to schedule kratom, which it deemed to be an “imminent hazard to public safety.”
Kratom remains legal throughout much of the U.S. Over the years, however, the FDA has ordered the seizure of products containing the plant.
While proponents of kratom note it has the potential to ease opioid withdrawal symptoms, critics allege that its risks outweigh its benefits.
Former FDA Commissioner Dr. Scott Gottlieb rallied against kratom over its opioid-like properties.
In 2018, Gottlieb wrote: “We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist.”
The U.S. opioid epidemic has steadily worsened since the 1990s. The pandemic has exacerbated the problem, leading to a 30% increase in drug overdoses in 2020 over the prior year. Roughly three-quarters of drug overdoses involve opioids.
The growing availability of the synthetic opioid fentanyl, which is 50 to 100 times more potent than morphine, has contributed to numerous deaths in recent years.
“There are currently only three FDA-approved therapeutics for OUD,” said Atai CEO Florian Brand in a news release. Those drugs include buprenorphine, methadone and naltrexone. “They produce side effects, and about 75% of patients undergoing OUD therapy experience relapse within one year of treatment. New alternatives could improve the treatment landscape of addiction.”
Atai Life Sciences believes that the atypical opioid receptor modulator KUR-101 is safer for chronic use than currently available OUD drugs and can be administered at a lower dose than mitragynine.
The deuterated form of mitragynine reportedly has superior pharmacokinetics and an improved safety profile over conventional mitragynine.
In mid-day trading, ATAI shares were down 2.70% to $3.24.
Last week, Atai announced a Phase 1 study of buccal and IV synthetic DMT for treatment-resistant depression.
Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs
